Non-Pharmacological Techniques to Reduce the Severity and Frequency of Emergency Reactions After Procedural Sedation and Analgesia in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- STAI-6
研究概览
简要总结
The objectives of this study are first to determine if the power of suggestion will decrease the frequency and severity of emergence reactions after procedural sedation and analgesia with ketamine in the setting of the emergency department. Second, to determine if people dream about what they were thinking about when they were induced with ketamine.
详细描述
The proposed research will be single blinded (patient) randomized controlled trial with a retrospective component to test the hypothesis that the power of suggestion will reduce the frequency and severity of emergence reactions, even in the setting of the emergency department.
The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital. CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in south Texas. It is a major teaching affiliate of Texas A&M medical school, and serves an inner-city population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
During the consent for the study, the physician will do the following depending on which group the patient has been randomized to: Packet 1: The physician will be asked to instruct the patient as empathetically and confidently as possible, that the drug the patient will be given will make them feel not pain, cause them to forget the procedure, and allow them to dream the dream of their choice. The resident will specifically ask the patient what he or she wants to dream about and the resident will then write the patient's answer on the instruction sheet. Packet #2: They physician will be asked to read a written statement about how the drug they will be given will cause analgesia, amnesia, and may cause hallucinations.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 18 years of age
- •Required need for procedural sedation and analgesia
排除标准
- •Hypertension
- •Raised Intracranial pressure
- •Major psychological disorders
- •Procedures involving laryngel manipulations
- •History of Laryngeal sapsm History of adverse reactions to ketamine
结局指标
主要结局
STAI-6
时间窗: 24 months
To ensure two groups are similar to each other -demographic data, the pre and post opt sedation VAS scores, and the STAI-6 information.
T-Test
时间窗: 24 months
Data gathered from post sedation questionnaire, specifically question 5, will be analyzed by comparing the two means of group one and group two using a student's T test,
次要结局
未报告次要终点